About
Talc is a naturally occurring hydrated magnesium silicate mineral (Mg3Si4O10(OH)2) used in food as an anticaking agent, glazing agent, bulking agent, filtering aid, chewing gum base compound, and thickener. The Codex INS number is 553(iii) while the EU designates the same substance as E553b.
Safety summary
EFSA's 2018 re-evaluation concluded that safety of talc as a food additive cannot be fully assessed due to insufficient toxicological data, and the previously established SCF group ADI of 'not specified' was declared obsolete. JECFA had previously assigned an ADI of 'not specified' based on very low oral absorption and no indication of genotoxicity or developmental toxicity at dietary intake levels. Historical contamination with asbestos-form fibres has been addressed through strict food-grade purity specifications requiring asbestos-free material.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| Health Canada (Canada) | Approved | Permitted food additive under B.01.045 of the Food and Drug Regulations; must meet food-grade specifications set out in the most recent Food Chemicals Codex or JECFA Combined Compendium; must be free from asbestos. JECFA ADI 'not specified' noted as applicable reference.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | FSSAI aligns with Codex Alimentarius standards; talc is recognized under INS 553(iii) in the Codex General Standard for Food Additives (GSFA). Specific permitted food categories and maximum use levels follow Codex/JECFA guidance. Food-grade purity specifications must be met.source |
| FDA (Food and Drug Administration) (United States) | Approved | Talc is recognized as GRAS for specific uses including food packaging (indirect food additive) and listed in 21 CFR parts 175–178 as an authorized food contact substance. Also used as a direct food additive (anticaking agent, release agent) in specific food categories under FDA regulations.source |
| EFSA (European Food Safety Authority) (European Union) | Under_review | EFSA 2018 re-evaluation (ANS Panel) concluded safety cannot be assessed due to data gaps; SCF group ADI 'not specified' declared obsolete. European Commission called for new safety data from business operators under Commission Regulation (EU) No 257/2010; if sufficient data are not submitted, authorization under Regulation (EC) No 1333/2008 may be revised or removed. Authorized uses include surface treatment of certain confectionery, rice, and chewing gum. Designated E553b in EU. |
Who should approach with care
Research citations
- 1WHO. JECFA Food Additive Database: Talc (INS 553iii). apps.who.int
- 2other. Screening Assessment – Talc (Health Canada / Environment and Climate Change Canada). canada.ca
- 3other. European Commission Re-evaluation Programme Follow-up: Calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b). food.ec.europa.eu
- 4EFSA. Re-evaluation of calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b) as food additives, 2018. efsa.europa.eu
- 5PubMed. Re-evaluation of calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b) as food additives, 2018. pubmed.ncbi.nlm.nih.gov